BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1952058 · Received January 3, 2011

    Report

    Report Number
    1820334-2011-00001
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    November 26, 2010
    Report Date
    December 6, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PROCEDURES NOT SPECIFICALLY LABELED IN THE IFU. ENDOLEAKS ARE LABELED IN THE IFU. THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, PROPER BALLOONING SITES, F/U GUIDELINES. SPECIFICALLY, THE IFU STATES THAT THE DEVICE IS INTENDED FOR PTS HAVING AN INFRARENAL AORTIC NECK WITH LESS THAN A 60 DEGREE ANGLE RELATIVE TO THE LONG AXIS OF THE ANEURYSM. SEVERE NECK ANGULATION MAY COMPROMISE THE PROXIMAL FIXATION SITE. THE DEVICE WAS USED OFF-LABEL DUE TO ANATOMICAL EXCLUSION. PT ANATOMY LIKELY CONTRIBUTED TO THE REPORTED TYPE 1A. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE CONTRIBUTED TO THE EVENT. PLACEMENT OF ANOTHER MFR'S STENT IN A SECONDARY PROCEDURE RESOLVED THE ENDOLEAK. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT (QERA) AND THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) OLD MALE PT UNDERWENT AAA REPAIR UNDER GENERAL ANESTHESIA ON (B)(6) 2008. THE PT'S PROXIMAL NECK WAS MORE THAN 60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM. A MAINBODY AND TWO ILIAC LEGS WERE PLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ENDOLEAKS. AT A F/U ON (B)(6) 2010, A PROXIMAL TYPE I ENDOLEAK AND A TYPE II ENDOLEAK FROM THE INFERIOR MESENTERIC ARTERY WERE CONFIRMED. ON (B)(6) 2010, TWO PALMAZ STENTS WERE ADDITIONALLY PLACED IN THE PROXIMAL NECK AND THE LEAK WAS SOLVED. THE PT'S CONDITION IS UNK AS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2537623

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention